Department of Health and Human Services
|Food and Drug Administration|
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: (510) 337-6700
Via UPS OVERNIGHT DELIVERY
July 13, 2015
Nelli Hugh, President
Ham Produce and Seafood, Inc.
918 Bannister Street
Honolulu, Hawaii 96819
Dear Ms. Hugh:
We inspected your seafood processing facility located at 748 Puuhale Road, Honolulu, Hawaii between the following dates: May 13 to May 20, 2015. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your fresh, refrigerated seafood products, including your histamine forming fish, tuna, are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
We acknowledge receipt of your firm’s May 30, 2015 letter in response to the FDA 483 List of Observations we issued to you at the close of our current inspection. Your response does not adequately address all the deviations observed. The deviations listed in this letter are based on observations we made during the inspection and our review of your response letter.
Your significant violations are as follows:
1. You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control pathogen growth and histamine formation when your process for tuna, intended for raw consumption, deviated from your critical limit at the Cold Storage critical control point.
Specifically, your critical limit at the Cold Storage CCP is “(b)(4)” as stated on your firm’s HACCP plan for Tuna entitled “ALL SEAFOOD INTENDED FOR RAW CONSUMPTION / HISTAMINE” dated November 10, 2014. On April 4, 2015, your manual temperature record for your upstairs cooler documented the temperature of 42°F at 3:05 pm, which is over your critical limit, but no corrective action was taken. On May 13, 2015, we observed your temperature data logger for your upstairs cooler documented the temperatures exceeded your critical limit between the following times with the following temperature ranges, but no corrective actions were taken:
04:14:10 to 04:46:19 41 to 46°F
09:48:19 to 10:42:19 41 to 46°F
15:51:19 to 16:24:19 41 to 48°F
21:52:19 to 22:30:19 41 to 47°F
We acknowledge in your May 30, 2015 response that you were under the impression that the critical limit is a “continuous cumulative time of 4 hours” and the times observed were within this limit. You stated that “[M]oving forward, time evaluations will be written more detailed and any root causes will be addressed and corrected accordingly.” Your response is not adequate. Please note that the cumulative time is the addition of all the time periods at which the temperature had exceeded 40°F; it does not need to be continuous. If you choose this control approach, the critical limit for cumulative exposure to temperatures above 40°F should include time during transit, refrigerated storage, and refrigerated and unrefrigerated processing.
Please refer to Chapter 7 (Scombrotoxin (Histamine) Formation) and Chapter 12 (Pathogenic Bacteria Growth and Toxin Formation as a Result of Time and Temperature Abuse) of the Fish and Fisheries Products Hazards & Controls Guidance: Fourth Edition for additional information related to the hazards and appropriate control strategies for storage of your products.
2. You must implement the recordkeeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not record monitoring observations at the Cold Storage critical control point to control pathogenic bacteria growth and histamine formation listed in your HACCP plan for Tuna, intended for raw consumption. Specifically, you are not maintaining a “(b)(4)” and documenting a record of your “(b)(4).”
We acknowledge in your May 30, 2015 response that temperature data logger printouts will be kept and stored as part of the record procedure for the Cold Storage Step CCP and that visual checks of the printouts will be documented via signatures at least once per day. We will verify the adequacy of this corrective action during our next scheduled inspection.
3. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the following specific areas of sanitation with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
A. Safety of water that comes into contact with food or food contact surfaces, or is used in the manufacturer of ice [21 CFR 123.11(b)(1)].
On May 13, 2015, our investigators observed that the ice used to cover tuna intended for raw consumption was contained in a dirty plastic bin with fish debris.
We acknowledge in your May 30, 2015 response that you will prevent possible cross contamination of fish debris by cleaning fish in a designated area away from the ice machine. However, you have not specified your corrective action taken regarding the dirty ice container.
B. Prevention of cross-contamination [21 CFR 123.11(b)(3)].
i) On May 13, 2015, our investigators observed cutting knives being stored in insanitary areas, for examples, inserted in between an electrical conduit and the wall and in between a water pipe and the wall. These cutting knives were used to cut fish, including tuna, intended for raw consumption, without first being washed or sanitized before use.
We acknowledge in your May 30, 2015 response that you have retrained your employees to store the knives into buckets of sanitizing solution in between uses. We will verify the adequacy of this corrective action during our next scheduled inspection.
ii) On May 13, 2015, our investigators observed the plastic strip curtains dragging over outgoing trash and over incoming un-processed tuna, intended for raw consumption.
We acknowledge in your May 30, 2015 response that you have replaced the plastic strip curtains and increased the frequency of sanitizing the strip curtains. However, this is not adequate in that you have not addressed how you will prevent incoming tuna from touching the plastic strip curtains after the curtains have touched insanitary objects such as trash.
iii) On May 13, 2015, our investigators observed your employees exiting and entering the facility without washing or sanitizing their hands before going to their work station to handle tuna intended for raw consumption.
Your May 30, 2015 response did not address a corrective action to this observation.
C. Exclusion of pests from the food plant [21 CFR 123.11(b)(8)]
Our investigators observed several flying insects in the receiving area.
This item was discussed with you at the conclusion of the inspection and your May 30, 2015 response did not addressed this observation.
The above violations are not intended to be an all-inclusive list of violations at your firm.
We may take further action if you do not promptly correct these violations. For instance, we may seize your product(s) and/or enjoin your firm from operating.
We also offer the following comment: You must conduct a hazard analysis for each of your seafood products to determine whether there are food safety hazards that are reasonably likely to occur and you must have a written HACCP plan to control the food safety hazards that are reasonably likely to occur.
Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the attention:
Lawton W. Lum
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
Please reference CMS # 472521 in your response.
If you have any questions regarding any issue in this letter, please contact Juliane Jung-Lau, Compliance Officer, at 510-337-6793.
Kathleen M. Lewis, J.D.
San Francisco District Director